Ultrasonic angioplasty-atherectomy catheter and method of use

ABSTRACT

An ultrasonic device and method for removing obstructive matter from an anatomical structure or passageway (e.g., blood vessel). The device comprises an elongate pliable catheter having a distal tip member attached to the distal end thereof, and an ultrasound transmission member which extends longitudinally therethrough to carry ultrasound from the proximal end of the catheter to the distal tip member. The distal tip member has a concave indentation formed in the distal surface thereof, and at least one inlet passageway extending therethrough in communication with a catheter lumen to facilitate suctioning of severed matter which becomes located within the concave indentation of the distal tip. The device may further incorporate means for infusing fluid (e.g., irrigation fluid, medicaments) separately or concurrently with the aspiration of the severed obstructive matter.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.08/094,416, filed Jul. 19, 1993 now U.S. Pat. No. 5,397,301 which is adivision of Ser. No. 640,190 filed Jan. 11, 1991 now U.S. Pat. No.5,304,115 and of U.S. patent application Ser. No. 08/255,513 filed Jun.8, 1994, now U.S. Pat. No. 5,474,530 which is a division of Ser. No.911,651, filed Jul. 10, 1992 and issued on Jun. 28, 1994 as U.S. Pat.No. 5,324,255.

FIELD OF THE INVENTION

The present invention pertains generally to medical equipment and moreparticularly to an atherectomy catheter having an ultrasoundtransmission member extending therethrough such that ultrasonic energymay be delivered to the distal end of the catheter to facilitate theatherectomy procedure.

BACKGROUND OF THE INVENTION

The prior art has included a number of ultrasonic catheters which areinsertable into the mammalian body and usable to deliver ultrasonicenergy for purposes of ablating obstructive material from anatomicalcavities or passageways, or for other therapeutic purposes.

Examples of ultrasonic treatment catheters and related apparatus includethose described in U.S. Pat. Nos. 3,433,226 (Boyd), 3,823,717 (Pohlman,et al.), 4,808,153 (Parisi), 4,936,281 (Stasz), 3,565,062 (Kuris),4,924,863 (Sterzer), 4,870,953 (Don Michael, et al.), 4,920,954(Alliger, et al.), 5,267,954 (Nita), as well as other patentpublications WO87-05739 (Cooper), WO89-06515 (Bernstein, et al.),WO90-0130 (Sonic Needle Corp.), EP316789 (Don Michael, et al.),DE3,821,836 (Schubert) and DE2,438,648 (Pohlman).

Additionally, ultrasound transmitting catheters may be utilized todeliver ultrasonic energy to mammalian blood vessels for the purpose ofpreventing or reversing vasospasm, as described in U.S. Pat. No.5,324,255.

The prior art has also included a number of atherectomy devices whichare insertable into blood vessels and usable to cut, shave or otherwisesever obstructive matter from the walls of the blood vessel. Suchatherectomy devices typically include aspiration channels for suctioningthe severed matter from the lumen of the blood vessel. Examples ofatherectomy devices which have heretofore been know include thosedescribed in U.S. Pat. No. 5,100,423 (Fearnot),

Additionally, U.S. Pat. No. 4,808,153 (Parisi) has described a devicefor removing placque from arteries wherein a hollow tip member ismounted on the distal end of a tubular catheter, and an ultrasoundsource is connected to the proximal end of the catheter to cause theentire catheter, including the distal tip, to undergo vibratorymovement. Such vibratory movement of the hollow distal tip memberostensibly creates heat which serves to emulsify obstructive matterwhich is located on the walls of an artery adjacent the vibrating hollowtip member. The emulsified matter is subsequently suctioned orwithdrawn, in the proximal direction, through the hollow tip member andthrough the lumen of the catheter.

Although the device described in U.S. Pat. No. 4,808,153 (Perisi) ispurportedly useable to remove obstructive matter from the walls of ablood vessel, the device disclosed in such prior United States patent isbelieved to be of less than optimal design for all intravascularapplications. Accordingly, there remains a need for a new ultrasonicangioplasty catheter capable of utilizing ultrasound-induced vibratorymotion to sever or separate obstructive matter from the walls of bloodvessels or other anatomical passageways, and which includes means forpromptly removing the severed or separated matter from the lumen of theblood vessel or anatomical passageway.

SUMMARY OF THE INVENTION

In accordance with the present invention, there is provided anultrasonic device and method for removing obstructive matter from ananatomical cavity or passageway, such as a blood vessel. The device ofthe present invention generally comprises an elongate pliable catheterbody having a distal tip member attached to the distal end thereof. Anultrasound transmission member, such as a metal wire, extendslongitudinally through the catheter body to transmit ultrasonicvibratory movement from the proximal end of the catheter body, to thedistal tip member. In this regard, the proximal end of the ultrasoundtransmission member is connectable to an ultrasonic transducer or otherultrasound generating device. The ultrasound transmission member issubstantially unattached to the catheter body, such that the ultrasoundtransmission member may vibrate or move independent of the catheterbody. The distal tip member may be attached to the distal end of thecatheter body such that, ultrasonic vibratory movement transmitted tothe distal tip member may also cause a distal portion of the catheterbody to vibrate or move. A concave indentation is formed on the distalface of the distal tip member, and at least one aspiration passagewayextends longitudinally through the distal tip member, from the distalface thereof to the proximal end thereof, in communication with a lumenof the catheter body such that matter which becomes located within theconcave indentation of the distal tip member may be aspirated, in theproximal direction, through the aspiration passageway and through thecatheter body. The ultrasonic device of the foregoing characterinsertable into the desired anatomical cavity or passageway (e.g., bloodvessel) and advance to a point where the distal tip member is adjacent aquantity of obstructive matter to be removed. Thereafter, ultrasonicenergy is passed through the ultrasound transmission member to thedistal tip member, thereby causing ultrasonic vibratory movement of thedistal tip member. The catheter is then further advanced such that theconcave indentation in the distal face of the distal tip member comes incontact with the obstructive matter, and the ultrasonic vibratorymovement of the distal tip member causes the obstructive matter to beseparated or severed thereby. The separated or severed obstructivematter is then aspirated through the aspiration passageways, and throughthe catheter, thereby effecting complete removal of such matter.

Further in accordance with the invention, the elongate pliable catheterbody of the ultrasonic device of the foregoing character may comprise anouter tube having a hollow lumen of a lumenal diameter, and an innertube having an outer surface of an outer diameter. The inner tube isdisposed within the lumen of the outer tube, and the distal ends of bothtubes are affixed or positioned in abutment with the distal tip member.The aspiration passageway(s) of the distal tip member is incommunication with the lumen of the inner tube, such that severedparticles of obstructive matter may be suctioned through the aspirationpassageway and through the lumen of the inner tube. Additional fluidinfusion passageways may be formed through the distal tip member, incommunication with the lumenal surface of the outer tube. In thisregard, irrigation fluid, medicaments or other fluid may be infusedthrough such lumenal space and out of the outlet passageway(s) formed inthe distal tip member.

Further in accordance with the invention, there is provided a method ofremoving obstructive matter from an anatomical passageway, said methodcomprising the steps of:

a) providing an ultrasonic catheter device which comprises:

an elongate pliable catheter body having a proximal end, a distal end,and at least one lumen extending longitudinally therethrough;

a distal tip member attached to the distal end of said catheter body,said distal tip member having a distal surface, a concave indentationbeing formed in said distal surface;

an ultrasound transmission member extending longitudinally through saidcatheter body to transmit ultrasound from an ultrasound source locatedadjacent the proximal end of said catheter body, through said catheterbody, to said distal tip member;

at least one aspiration passageway extending longitudinally through saiddistal tip member from the proximal surface thereof to the distalsurface thereof, said aspiration passageway being in communication witha lumen of said catheter such that matter which becomes located withinthe concave indentation of said distal tip member may be aspirated, inthe proximal direction, through said passageway and through said lumenof said catheter.

b) inserting said catheter body into said anatomical passageway whereinsaid obstructive matter is located;

c) advancing said catheter body to a point where said distal tip memberis located adjacent the obstructive matter to be removed;

d) passing ultrasound through said ultrasound transmission memberthrough said distal tip member, thereby causing said distal tip memberto undergo ultrasonic vibratory movement;

e) advancing said catheter body such that the concaved distal surface ofsaid distal tip member comes into contact with said obstructive matter,and such that the ultrasonic vibratory movement of said distal tipmember facilitates severance of a portion of said obstructive matter;and

f) causing a severed portion of said obstructive matter to be aspiratedin the proximal direction, through said aspiration passageway, andthrough a lumen of said catheter body.

Additionally the method may include the step of infusing irrigationfluid or medicaments into the region where the obstructive matter islocated. Such infusion of irrigation fluid or medicaments may occurseparately from, or contemporaneously with, the severing, separationand/or removal of the obstructive matter.

Further objects and advantages of the present invention will becomeapparent to those skilled in the art upon reading and understanding ofthe following detailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1, is an elevation view of a preferred ultrasoundangioplasty-atherectomy catheter of the present invention.

FIG. 2, is an enlarged longitudinal sectional view of a proximal portionof the catheter shown in FIG. 1.

FIG. 3, is an enlarged longitudinal sectional view of a distal portionof the catheter shown in FIG. 1.

FIG. 4a-4c, is a step-by-step illustration of a presently preferredmethod for performing ultrasonic angioplasty-atherectomy using thecatheter of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following detailed description of and the accompanying drawings areprovided for purposes of describing and illustrating presently preferredembodiments of the invention only, and are not intended to limit thescope of the following claims in any way.

As shown in the drawings, the presently preferred ultrasonic atherectomycatheter 10 of the present invention comprises an elongate pliablecatheter body 12 having at least one hollow lumen 14 extendinglongitudinally therethrough. A distal tip member 16 is mounted within oron the distal end of the catheter body 12. A proximal connector assembly18 is mounted on or connected to the proximal end of the catheter body12 to facilitate connection of the catheter device 10 to an ultrasoundtransducer or other device capable of generating ultrasonic vibratorymovement. In the embodiment shown, the catheter body 12 is formed of anouter tube 20 having an outer tube lumen 22 extending longitudinallytherethrough, and an inner tube 24 which has an inner tube lumen 26extending longitudinally therethrough. The inner tube 24 is preferablypositioned co-axially within the lumen 22 of the outer tube 20, suchthat an annular peripheral portion of the outer tube lumen 22 surroundsthe outer surface 28 of the inner tube 24.

The outer tube 20 and inner tube 24 are concomitantly connected or heldin abutment with the distal tip member 16, such that the respectivedistal ends of the outer 20 and inner 24 tubes are securely held intheir desired coaxial positions. In the embodiment shown, the distal tipmember 16 comprises a generally cylindrical rigid body having an annularshoulder 30 formed around the proximal surface thereof, so as to definea generally cylindrical inner region 32 which protrudes in the proximaldirection from the center of the distal tip member 16. The diameter D₁of the cylindrical central projection 32 is substantially the same asthe inner diameter of the distal end of the inner tube 24, and thedistal end of the inner tube 24 is fitted over the central projection32, with the distal tip of the inner tube abutting against shoulder 30.The outer diameter D₂ of the remaining portion of the tip member 16 issubstantially the same of the inner diameter of the outer tube 20, suchthat the remaining body of the distal tip members 16 may be securelyfitted within the distal end of the outer tube 20, as shown. Adhesive,heat fusing techniques, or other fusion method may be utilized tosecurely hold the distal tip member 16 within the distal end of theouter tube 20. Similarly, adhesive, heat fusing or other fusiontechnique may be utilized to securely hold the distal end of the innertube 24 in contact with the central projection 32 on the proximal end ofthe distal tip member 16.

The frontal surface of the distal tip member 16 is provided with aconcave indentation 34.

A guidewire passage bore 37 is formed longitudinally through the centerof the distal tip member 16, and a guidewire tube 36 extendstherethrough. The distal end of the guidewire tube 36 opens through adistal guidewire aperture formed in the center of the concaveindentation 34, at the distal end of the catheter 10. The proximal endof the guidewire tube 36 is affixed within or about a proximal guidewirepassage aperture 38. In the embodiment shown in the drawings, theproximal guidewire aperture 38 is formed in the sidewall of the outertube 20, at a location approximately 10-30 cm from the distal end DE ofthe catheter body 12. A corresponding passage hole or opening 40 isformed in the wall of the inner tube 24, to permit the guidewire tube 36to exit therethrough. Such passage or opening 40 in the wall of theinner tube 24 is fused or sealed about the outer surface of theguidewire tube 36, thereby preventing fluid leakage through the passageor opening 40, about the guidewire tube 36. It will be appreciated thatthe specific embodiment shown in the drawings is a "monorail" type ofcatheter, wherein the guidewire tube 36 extends through only thedistal-most portion of the catheter body 12. Alternative "over the wire"embodiments of the invention may also be provided wherein the guidewiretube 36 extends longitudinally through the entire catheter body 12, andwherein the proximal end of the guide wire tube 36 is affixed to oropens through a guidewire entry aperture or sidearm located in theproximal connector assembly 18 of the catheter device 10.

In the "monorail" embodiment shown in the drawings, a guidewire GW, suchas a standard cardiovascular guidewire of the type commonly used inmodern clinical medicine having an outer diameter of 0.008-0.025 inches,may be inserted into the guidewire bore 37, and the catheter device 10may then be advanced in the distal direction over the guidewire GW suchthat the proximal end of the guidewire GW will emerge through theproximal guidewire aperture 38. In this manner, the catheter device 10may be advanced over a prepositioned guidewire in accordance withstandard cardiovascular catheterization technique.

An ultrasound transmission member 50 extends longitudinally through thelumen 26 of the inner tube 24 and is connected or held in abutment, atits distal end, with the distal tip member 16. The proximal end of theultrasound transmission member 50 is connected to or held in abutmentwith a sonic connector 52 which is formed on or extends from theproximal connector assembly 18. When an ultrasound transducer, or otherdevice capable of generating ultrasonic vibratory movement is connectedto the sonic connector 52, the ultrasonic vibratory movement emittedthereby is transmitted through the ultrasound transmission member 50, tothe distal tip member 16.

In the preferred embodiment, the ultrasound transmission member 50 ispreferably formed of a metal alloy, or other material, which exhibitssuperelastic properties within the range of operating temperaturesnormally encountered by the ultrasound transmission member 50 duringuse. One suitable superelastic material usable to form the ultrasoundtransmission member 50 is a nickel-titanium alloy having 50.8 atomicpercent nickel, balance titanium.

The preferred proximal connector assembly 18 comprises a distal portion60, a proximal portion 62, and a sonic connector housing portion 63. Thedistal portion 60 comprises a tubular hard plastic tube having afluid/debris aspiration sidearm 62 extending at an angle therefrom. Anaperture or opening 64 is formed in the rigid tubular body of the distalportion 60 such that fluid/debris may be aspirated from the lumen 22 ofthe outer tube 20, through aspiration sidearm 62, via hole or aperture64. A distal nut 66 and pliable plastic sleeve 68 are attached about theouter surface of the proximal portion of the outer tube 20, therebysecurely fastening the outer tube 20 to the distal portion 60 of theproximal connector assembly 18.

As shown in FIG. 2, the outer tube 20 and inner tube 24 extendlongitudinally through the distal portion 60 of the proximal connectorassembly 18, to a point adjacent the proximal nut 68 which conjoins theproximal portion 62 to the distal portion 60. At that location, thedistal end of the outer tube 20 is fused, or compressively held incontact with, the outer surface of the inner tube 24, so as to preventfluid within the lumen 22 of the outer tube 20, from leaking in theproximal direction beyond the location of second nut 68. The proximalportion 62 of the proximal connector assembly 18 comprises a rigidtubular plastic body, and the lumen 26 of the inner tube 24 extends andopens into the inner bore 70 of the proximal portion 62, as shown. Afluid infusion sidearm 72 extends from the rigid tubular body of theproximal portion 62, to permit infusion of fluid into the bore 70 of theproximal portion 62, and into and through the lumen 26 of the inner tube24.

The sonic connector 52 of the proximal connector assembly 18 is housedwithin a connector housing 63, which connector housing 63 is threadablymounted on the proximal end of the proximal portion 62. A pliableplastic tube 74 extends through the sonic connector housing 63, andprotrudes partially into the hollow inner bore 70 of the proximalportion 62, as shown. The ultrasound transmission member 50 extends fromthe sonic connector 52, through the pliable plastic tube 74, through thehollow inner bore 70 of the proximal portion 62, and into the lumen 26of the inner tube 24. Such ultrasound transmission member 50 thencontinues longitudinally though the lumen of the inner tube 24, to itsdistal end which, as described above, is affixed to or held in abuttingcontact with the distal tip member 16 of the catheter device 10.

O-rings 80, 82 are positioned within a threaded frontal cavity 84,formed in the distal portion of the sonic connector housing 63. Theproximal end of the proximal portion 62 is threaded, and is receivedwithin the threaded frontal bore 84 of the sonic connector housing 63such that O-rings 80, 82 are compressed thereby. In this regard,pressure is exerted by O-rings 80, 82 inwardly against the outer surfaceof plastic tube 74, thereby stabilizing and holding the plastic tube 74in a centralized position. The outer diameter of the ultrasoundtransmission member 50 is only slightly smaller than the inner diameterof the plastic tube 74 such that the plastic tube 74 will limit possibleside to side movement of the adjacent portion of the ultrasoundtransmission member 50, while allowing the ultrasound transmissionmember 50 to freely move longitudinally back and forth. Such limitationon side-to-side vibratory movement of the ultrasound transmission member50, within the region of the plastic tube 74, serves to minimize thelikelihood of fracture or breakage of the ultrasound transmission member50, in the critical region closest to the point of connection to theultrasound transducer or other ultrasound source.

Thus, as shown in the step-wise illustration of FIGS. 4a-4c, thecatheter shown in FIGS. 1-3 may be initially inserted, over aprepositioned guidewire GW having a preferred diameter of 0.008-0.025inches, into an anatomical passageway such as a blood vessel BV whereina quantity of atherosclerotic plaque or other obstructive matter OM islocated. The guidewire GW is initially advanced through the obstructivematter OM, and the catheter device 10 is advanced to a point where thedistal end DE of the catheter body 12 is immediately adjacent theobstructive matter OM (FIG. 4a).

Thereafter, an ultrasound transducer/generator or other source ofultrasonic energy attached to the sonic connector 52 is energized so asto pass ultrasonic energy through the ultrasound transmission member 50,to the distal tip member 16, thereby causing the distal tip member 16 toundergo ultrasonic vibratory movement. The catheter body 12 issubsequently advanced such that the vibrating peripheral edges of theconcave indentation 34 of the vibrating tip member 16 cut into orseparate the obstructive matter OM. As the vibrating peripheral edge ofthe concave distal tip member 16 severs or cuts away particles orquantities of the obstructive matter OM, the severed particles orquantities of obstructive matter may be aspirated through debrisaspiration apertures 48, through debris/fluid aspiration pathways 46,through lumen 22, and out of the aspiration sidearm 62 located onproximal connector 18 (FIG. 4b). This will typically be accomplished byattaching a suction source to aspiration sidearm 62. A collection vesselmay also be provided to collect the debris or other matter receivedthrough aspiration, to permit such matter to be subsequently analyzedfor variation of the type and quantity of obstructive matter OM removed.

Also, apart from or during the procedure, quantities of irrigationfluid, medicaments, or other fluid may be infused through infusionsidearm 72, through lumen 26, through infusion outlet passageways 42,and out of infusion outlet apertures 44.

After the device 10 has been utilized to remove a sufficient amount ofthe obstructive matter OM to restore patency to the blood vessel BV orother anatomical passageway, the guidewire GW may be withdrawn and thecatheter body 12 may be withdrawn from the body, thereby leaving theblood vessel BV in a restored state of improved patency.

It will be appreciated that the present invention has been describedherein with reference to certain presently preferred embodiments of theinvention, and no effort has been made to exhaustively describe allpossible physical embodiments of the invention, or all possiblecomponents which may be utilized to practice the invention. In thisregard, various modifications, additions, deletions and alterations maybe made to the above-described embodiments without departing from theintended spirit and scope of the invention. Accordingly, it is intendedthat all such additions, deletions modifications and alterations beincluded within the scope of the following claims.

What is claimed is:
 1. An ultrasonic device for removing obstructivematter from an anatomical passageway, said device comprising:an elongatepliable catheter body having a proximal end, a distal end, and at leastone lumen extending longitudinally therethrough; a distal tip memberfixedly attached to the distal end of said catheter body for engagingthe obstructive matter, the distal tip member having a length selectedso that the entire distal tip member is contained within the distal endof the catheter body, said distal tip member having a distal surface; anultrasound transmission member extending longitudinally through saidcatheter body to transmit ultrasound from an ultrasound source locatedadjacent the proximal end of said catheter body, through said catheterbody, to said distal tip member; and at least one aspiration passagewayextending longitudinally through said distal tip member from theproximal surface thereof to the distal surface thereof, said aspirationpassageway being in communication with a lumen of said catheter suchthat matter located at the distal tip member may be aspirated, in theproximal direction, through said passageway and through said lumen ofsaid catheter.
 2. The ultrasonic device of claim 1 wherein said catheterbody comprises a pliable plastic cardiovascular catheter sized to beinserted into a mammalian blood vessel.
 3. The ultrasonic device ofclaim 1 wherein said catheter body comprises:an outer tube having aproximal end, a distal end and a hollow lumen of a luminal diameterextending longitudinally therethrough; and an inner tube having an outersurface of an outer diameter, a proximal end, a distal end, and a hollowlumen extending longitudinally therethrough; the outer diameter of saidinner tube being smaller than the luminal diameter of said outer tube,and said inner tube being disposed within the lumen of said outer tube.4. The ultrasonic device of claim 3 wherein said inner and outer tubeshave central longitudinal axes, and said inner tube is positionedcoaxially within the lumen of said outer tube.
 5. The ultrasonic deviceof claim 4 wherein the lumenal diameter of the outer tube is at least0.1 mm larger than the outer diameter of the inner tube, such that aluminal space of at least 0.1 mm exists between the lumenal surface ofthe outer tube and the outer surface of the inner tube.
 6. Theultrasonic device of claim 3 wherein said distal tip member is inabutting contact with the distal ends of said inner and outer tubes;andwherein the lumen of said outer tube is in communication with said atleast one aspiration passageway such that matter may be aspirated, inthe proximal direction, through said aspiration passageway and throughthe lumen of said outer tube.
 7. The ultrasonic device of claim 3further comprising:at least one outlet passageway extendinglongitudinally through said distal tip member from the proximal surfacethereof to the distal surface thereof; wherein the lumen of said outertube is in connection with said at least one aspiration pathway suchthat matter may be aspirated in the proximal direction, through saidaspiration pathway and through the lumen of said outer tube; and whereinthe lumen of the inner tube is in communication with said at least oneoutlet passageway such that fluid may be infused through said lumen,through said outlet passageway, and out the distal end of said catheterdevice.
 8. The device of claim 3 wherein the distal end of said innertube terminates a spaced-distance short of the distal end of said outertube, and wherein said distal tip member comprises:a generallycylindrical member having a generally cylindrical outer surface of adiameter substantially the same as the lumenal diameter of said outertube; an annular depression formed about the periphery of the proximalsurface of said tip member, said annular depression defining therewithina central cylindrical proximal extension; said distal tip member beinginserted into the distal end of said catheter body such that outercylindrical surface of said distal tip member is in abutment with theluminal surface of said outer tube, and such that the cylindricalproximal projection of said tip member is inserted into the distal endof the lumen of said inner tube.
 9. The ultrasonic device of claim 8wherein said at least one outlet passageway is formed longitudinallythrough said distal tip member, from the proximal surface of the centralproximal projection thereof, to the distal surface thereof such thatfluid may be infused from the lumen of the inner tube, through theoutlet passageway, and out of the distal end of the device.
 10. Theultrasonic device of claim 9 wherein the at least one aspirationpassageway extends longitudinally through said distal tip member fromthe annular shoulder formed in the proximal surface thereof to thedistal surface thereof and in communication with the lumenal spacebetween the lumenal surface of the outer tube and the outer surface ofthe inner tube such that matter may be aspirated from the distal surfaceof the distal tip member, through the aspiration passageway and into thelumenal space.
 11. The ultrasonic device of claim 10 furthercomprising:a plurality of aspiration passageways, each of which is incommunication with the lumenal space between the lumenal surface of theouter tube and the outer surface of the inner tube; and a plurality ofinfusion passageways, each of which is in communication with the lumenof the inner tube; whereby aspiration and infusion may occursimultaneously.
 12. The ultrasonic device of claim 3 furthercomprising:an infusion passageway formed through the distal tip member;a plurality of lumina disposed in the catheter body such that separatelumina are in communication with the aspiration passageway and theinfusion passageway; whereby aspiration and infusion may be performedsimultaneously.
 13. The ultrasonic device of claim 12 furthercomprising:a plurality of aspiration passageways each of which is incommunication with a first lumen of the catheter body; and a pluralityof infusion passageways, each of which is in communication with a secondlumen of the catheter body.
 14. The ultrasonic device of claim 1 whereinsaid ultrasound transmission member is formed of material which exhibitssuper elastic properties in the range of temperatures encountered bysaid ultrasound transmission member during operation of said device. 15.The ultrasonic device of claim 14 wherein the material of which saidultrasound transmission member is formed comprises nickel-titaniumalloy.
 16. The device of claim 14 wherein said nickel titanium allowconstitutes 50.8 anatomic percent nickel.
 17. The ultrasonic device ofclaim 1 further comprising:a guidewire passageway extendinglongitudinally through said distal tip member from the proximal endthereof to the distal end thereof, said guidewire passageway being incommunication with a lumen of said catheter body such that a guidewiremay be passed through the lumen of said catheter body and through saiddistal tip member.
 18. The ultrasonic device of claim 17 furthercomprising:a guidewire tube having a proximal end and a distal end, saidguidewire tube being disposed in a lumen of said catheter body, thedistal end of said guidewire tube being in communication with saidguidewire passageway formed in said distal tip member, and the proximalend of said guidewire tube being in communication with a proximalguidewire outlet aperture formed in said device at a location proximalto the distal end of said catheter body.
 19. The ultrasonic device ofclaim 18 wherein said proximal guidewire outlet aperture comprises anaperture formed in said pliable catheter body at a location 10-30 cmfrom the distal end of said catheter body.
 20. The ultrasonic device ofclaim 18 wherein said proximal guidewire aperture is located adjacentthe proximal end of said catheter body.
 21. The ultrasonic device ofclaim 1 further comprising:a proximal connector assembly mounted on theproximal end of said catheter body, said proximal connector assemblyincorporating a sonic connector apparatus whereby an external ultrasoundsource may be connected to the proximal end of said ultrasoundtransmission member.
 22. The ultrasonic device of claim 21 wherein saidproximal connector assembly further comprises:a suction outlet portlocated on said proximal connector assembly in communication with thelumen of said catheter body which is in communication with saidaspiration passageway, to facilitate aspiration of matter in theproximal direction, through said aspiration passageway, through saidlumen, and out of said suction port.
 23. The ultrasonic device of claim1 further comprising:at least one outlet passageway separated from theaspiration passageway, the outlet passageway extending longitudinallythrough said distal tip member, from the proximal surface thereof to thedistal surface thereof, said at least one outlet passageway being incommunication with a lumen of said catheter body such that fluid may beinfused through said lumen, through said outlet passageway, and out ofthe distal end of said catheter device.
 24. The device of claim 23further comprising:a proximal connector assembly mounted on the proximalend of said catheter body, said proximal connector assemblyincorporating a sonic connector apparatus whereby an external ultrasoundsource may be connected to the proximal end of said ultrasoundtransmission member and a fluid inlet port located on said proximalconnector assembly in communication with the lumen of the catheter bodywhich is in communication with said outlet passageway to facilitateinfusion of fluid, in the distal direction, through said fluid inletport, through said lumen, through said outlet passageway, and out of thedistal end of said device.
 25. The apparatus of claim 1 wherein saiddistal tip member is inserted into the distal end of a lumen of saidcatheter body, and secured to said catheter body by adhesive.
 26. Theapparatus of claim 1 wherein said distal tip member is inserted into thedistal end of a lumen of said catheter body, and secured to saidcatheter body by heat fusing.
 27. The ultrasonic device of claim 1wherein the distal tip member comprises a concave indentation formed inthe distal surface.
 28. The ultrasonic device of claim 1 furthercomprising:an infusion passageway formed through the distal tip member;a plurality of lumina disposed in the catheter body such that separatelumina are in communication with the aspiration passageway and theinfusion passageway; whereby aspiration and infusion may be performedsimultaneously.
 29. The ultrasonic device of claim 28 furthercomprising:a plurality of aspiration passageways each of which is incommunication with a first lumen of the catheter body; and a pluralityof infusion passageways, each of which is in communication with a secondlumen of the catheter body.
 30. A method for removing obstructive matterfrom an anatomical passageway, said method comprising the steps of:a)providing an ultrasonic catheter device which comprises:an elongatepliable catheter body having a proximal end, a distal end, and at leastone lumen extending longitudinally therethrough; a distal tip memberfixedly attached to the distal end of said catheter body for engagingthe obstructive matter, the distal tip member having a length selectedso that the entire distal tip member is contained within the distal endof the catheter body, said distal tip member having a distal surface; anultrasound transmission member extending longitudinally through saidcatheter body to transmit ultrasound from an ultrasound source locatedadjacent the proximal end of said catheter body, through said catheterbody, to said distal tip member; at least one aspiration passagewayextending longitudinally through said distal tip member from theproximal surface thereof to the distal surface thereof, said aspirationpassageway being in communication with a lumen of said catheter suchthat matter located at the distal tip member may be aspirated, in theproximal direction, through said passageway and through said lumen ofsaid catheter; b) inserting said catheter body into said anatomicalpassageway wherein the obstructive material is located; c) advancingsaid catheter body to a point where said distal tip member is locatedadjacent the obstructive matter to be removed; d) passing ultrasoundthrough said ultrasound transmission member through said distal tipmember, thereby causing said distal tip member to undergo ultrasonicvibratory movement; e) advancing said catheter body such that the distalsurface of said distal tip member comes into contact with saidobstructive matter, and such that the ultrasonic vibratory movement ofsaid distal tip member facilitates severance of a portion of saidobstructive matter; and f) causing a severed portion of said obstructivematter to be aspirated in the proximal direction, through saidaspiration passageway, and through a lumen of said catheter body. 31.The method of claim 30 wherein the catheter provided in step a) furthercomprises at least one outlet passageway which extends longitudinallythrough said distal tip member, in communication with a lumen of saidcatheter body, and wherein said method further comprises:g) infusingfluid through said lumen of said catheter body and out of said outletpassageways, in the area of said obstructive matter.
 32. The method ofclaim 31 wherein steps f and g are conducted separately.
 33. The methodof claim 31 wherein steps f and g are conducted concurrently.